Label at a glance#

ProductFiberlay Ethanol Disposable Gel Disinfectant

Active ingredientALCOHOL

Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Protect from light and store ina cool, dry, venilatdplace.

INACTIVE INGREDIENT SECTION

Deionized water

Glycerine

Carbomer

INDICATIONS & USAGE SECTION

1.Hygiene hands: Take an aprpiate amount of hand dsinfectant on the palm of your hands, rub your hands together for 1 minute to dsinfect.
2. Surgical hands: After surgical hand washing take an apropiate amount of hand dsinfecant and evenly apply it to the skin of the hands, forearm and lower third of the upper arm for 3min.
3. Skin: Apply the skin surface evenly for 3min.

OTC - ACTIVE INGREDIENT SECTION

Ethanol

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

OTC - PURPOSE SECTION

Disinfection
Sterilization
No Rinseing

WARNINGS SECTION

1.This is an extemal use dinfectant, please do not take titemallKeep itout of reach of children.

2. This product is fanmmable and away from fre sources.

3. Use with caution to those who are alergic to alcohol.

4. Protect from light and store ina cool, dry, venilatdplace.

5. Avoid couse withantagonist dugs.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1305100	Ethanol (Topical)	ethanol 0.75 ML/ML Topical Gel	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1305100	ethanol 75 % Topical Gel	PSN	1
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	1
1305100	ethanol 75 % Topical Gel	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53048-001-01	2022-01-28	C162847	48780-1	d6a99b39-8d0d-a426-e053-dadaa90af4c2	a63933b3-1a84-2d15-e053-2995a90accf0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53048-001-01	Fiberlay Ethanol Disposable Gel Disinfectant	500 mL in 1 BOTTLE	GEL	500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53048-001	FIBERLAY ETHANOL DISPOSABLE GEL DISINFECTANT (75% ETHANOLGEL) GEL [SHANDONG LUGANGFUYOU MEDICAL CO., LTD]	1	Legacy NDC, 1 package rows	20200523_a63933b3-1a84-2d15-e053-2995a90accf0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Fiberlay Ethanol Disposable Gel Disinfectant
75% Ethanolgel
ALCOHOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
GLYCERIN
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53048-001	53048-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	ACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a63933b3-1a85-2d15-e053-2995a90accf0			a63933b3-1a84-2d15-e053-2995a90accf0	2020-05-22	Warnings	Exact identifier spl id: a63933b3-1a85-2d15-e053-2995a90accf0 spl set id: a63933b3-1a84-2d15-e053-2995a90accf0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Fiberlay Ethanol Disposable Gel Disinfectant